FOLINATE CALCIUM NORMON 350 MG POWDER FOR INJECTABLE SOLUTION

2. What you need to know before using Calcium Folinate Normon

Do not use Calcium Folinate Normon:

• If you are allergic to calcium folinate or any of the other components of this medication (listed in section 6).
• If you have or have had pernicious anemia or other megaloblastic anemias due to vitamin B12 deficiency.

Warnings and precautions

• Calcium folinate should only be administered by intravenous or intramuscular injection (see

This information is intended only for doctors or healthcare professionals).

• Treatment with calcium folinate may mask pernicious anemia and other megaloblastic anemias resulting from vitamin B12 deficiency.

Consult your doctor or pharmacist before starting to use calcium folinate:

• If you are epileptic and are being treated with phenobarbital, phenytoin, primidone, and succinimides, as there is a risk of increased frequency of seizures.
• If you are being treated with antitumor medications such as:

5-Fluorouracil:

? Combination treatment may increase the toxicity of 5-Fluorouracil.

? In the case of elderly or debilitated patients, a dose reduction may be necessary.

? If you experience diarrhea, as this may be a symptom of gastrointestinal toxicity.

? Because during treatment, your doctor will need to monitor your blood calcium levels.

Methotrexate:

? In case of renal failure due to methotrexate, higher doses or longer use of calcium folinate may be necessary.

Other medications and Calcium Folinate Normon

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Certain medications may interact with calcium folinate; in these cases, it may be necessary to change the dose or discontinue treatment with one of them.

It is important that you inform your doctor if you are taking or have recently taken any of the following medications:

• Folic acid antagonists (e.g., cotrimoxazole, pyrimethamine) as their efficacy may be reduced when administered with calcium folinate.
• Antiepileptic medications: phenobarbital, primidone, phenytoin, and succinimides. Calcium folinate may reduce the effect of these medications and increase the frequency of epileptic seizures.
• 5-Fluorouracil, as the combined administration of calcium folinate with 5-fluorouracil has been shown to increase the efficacy and toxicity of 5-Fluorouracil.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

Calcium Folinate Normon has no effects on the ability to drive vehicles or use machines.

Calcium Folinate Normon contains sodium

This medication contains 55.6 mg of sodium (main component of table salt/cooking salt) per vial. This is equivalent to 2.78% of the maximum daily recommended sodium intake for an adult.

3. How to use Calcium Folinate Normon

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember that your medication is administered to you.

Your doctor will indicate the duration of your treatment with calcium folinate. Do not discontinue treatment before completing it, as you will not achieve the desired therapeutic effect.

Since calcium folinate increases the toxicity of 5-Fluorouracil, treatment with the combination of both should be supervised by an experienced doctor in the use of anticancer medications.

If you use more Calcium Folinate Normon than you should:

If you are administered more calcium folinate than recommended, your doctor will treat you accordingly. No significant harm has been reported in patients who have received significantly higher doses of calcium folinate than recommended. If you are administered too much calcium folinate in combination with methotrexate, it may reduce the effect of this medication.

If an overdose of the combination of 5-fluorouracil and calcium folinate occurs, follow the overdose instructions for 5-fluorouracil.

In case of overdose, consult the Toxicology Information Service (Telephone 91 562 04 20), indicating the medication and the amount administered.

If you forget to use Calcium Folinate Normon

Do not use a double dose to make up for forgotten doses.

If you interrupt Calcium Folinate Normon

When calcium folinate is administered in combination with methotrexate and treatment is interrupted abruptly, the side effects of methotrexate that were previously counteracted by calcium folinate may appear. Therefore, it is not advisable to interrupt the administration of calcium folinate abruptly.

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone experiences them.

The following side effects may occur:

Uncommon side effects: may affect up to 1 in 100 people

Fever has been observed after administration of calcium folinate as an injectable solution.

Rare side effects: may affect up to 1 in 1,000 people

Insomnia, agitation, and depression after high doses. Increased frequency of seizures in epileptics.

Very rare side effects: may affect up to 1 in 10,000 people

Allergic reactions, including urticaria.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Calcium Folinate Normon

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe particles in suspension after reconstitution or if you observe coloration.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Calcium Folinate Normon:

• The active ingredient is folinic acid, each vial contains 350 mg of folinic acid (in the form of calcium folinate).
• The other components (excipients) are: sodium chloride, sodium hydroxide, hydrochloric acid, and nitrogen.

Appearance of the product and package contents:

Calcium Folinate Normon 350 mg is presented as a powder for injectable solution.

The vial is made of type I glass, transparent, colorless, closed with a gray rubber stopper and sealed with a flip-off aluminum cap.

Each package contains 1 or 25 vials (clinical package). After reconstitution, the solution contains a concentration of

20 mg/ml.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

THIS INFORMATION IS INTENDED ONLY FOR DOCTORS OR HEALTHCARE PROFESSIONALS:

Reconstitution

Reconstitute the vial with 17.5 ml of water for injection.

Method of administration

For intravenous or intramuscular administration only. In the case of intravenous administration, do not inject more than 160 mg of calcium folinate per minute due to the calcium content of the solution. For intravenous perfusion, calcium folinate can be diluted with 0.9% sodium chloride solution or 5% glucose solution, obtaining a concentration of 0.5 mg/ml, before use.

For intramuscular administration, consider the volume restriction of this administration route.

Incompatibilities

When using Calcium Folinate Normon, consider the following incompatibilities: Calcium Folinate Normon should not be mixed with injectable forms of droperidol, fluorouracil, foscarnet, and methotrexate. When mixed with droperidol, immediate precipitation occurs. When mixed in the same perfusion with 5-fluorouracil, a precipitate may form. When mixed with foscarnet, a yellowish turbid solution forms.

Storage after reconstitution

It is recommended that the reconstituted solution be administered immediately. However, it can be stored for 8 hours at a temperature not exceeding 25°C or in a refrigerator (2°C-8°C) for a maximum of 24 hours.

OTHER PRESENTATIONS

Calcium Folinate Normon 50 mg powder and solvent for injectable solution EFG

Date of the last revision of this leaflet:February 2021.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.